Summary Background Sexually transmitted and urogenital infections are typically managed by WHO-recommended syndromic algorithms in resource-poor countries, and presumptively in Europe. However, algorithms for vaginal discharge and lower abdominal pain perform poorly in women. The women's improvement of sexual and reproductive health (WISH) study in Kigali, Rwanda, sought to improve case-finding and infection management in women by introducing point-of-care tests. The main aim was to compare the performance of the WISH algorithms and the WHO vaginal discharge and lower abdominal pain algorithms with gold standard testing. Methods This cross-sectional screening and diagnostic accuracy study recruited women aged 18 years or older with or without urogenital symptoms at risk of acquiring sexually transmitted infections in Kigali, Rwanda. Recruitment activities were implemented by study staff with the help of community mobilisers at health centres, pharmacies, markets, women's organisations, and at "umuganda" community meetings. At the study visit, participants had a face-to-face interview that included questions about current urogenital symptoms. Participants were first asked without prompting (spontaneous reporting), followed by questions about 14 specific symptoms (structural reporting). Next, the WISH algorithms were implemented. All participants had point-of-care tests for bacterial vaginosis (vaginal pH of 5·0 or above) and Trichomonas vaginalis (immunoassay) regardless of symptom reporting. Women with a positive risk score had point-of-care tests for Chlamydia trachomatis and Neisseria gonorrhoea (nucleic acid amplification tests). Vulvovaginal candidiasis was treated presumptively. Nucleic acid amplification tests for C trachomatis, N gonorrhoeae, T vaginalis, bacterial vaginosis, and vulvovaginal candidiasis were the gold standard, and all patients provided swabs for these. Findings Participants were recruited between July 5, 2016, and March 14, 2017. 705 participants were enrolled in the study and completed a study visit, and 51 attended 53 additional visits. Prevalence by gold standard testing was 8·5% for C trachomatis, 7·1% for N gonorrhoeae, 16·1% for T vaginalis, 18·1% for bacterial vaginosis, and 8·6% for vulvovaginal candidiasis. The WISH algorithms identified similar numbers of C trachomatis, N gonorrhoeae, and T vaginalis infections, but much higher numbers of bacterial vaginosis and vulvovaginal candidiasis infections. Compared with gold standard testing, the WISH algorithms had a good sensitivity and high specificity for C trachomatis (sensitivity 71·7%, specificity 100%), N gonorrhoeae (sensitivity 76·0%, specificity 100%), and T vaginalis (sensitivity 68·5%, specificity 97·4%), high sensitivity but low specificity for bacterial vaginosis (sensitivity 95·2%, specificity 41·2%), and moderate sensitivity and specificity for vulvovaginal candidiasis (sensitivity 64·4%, specificity 69·4%). The performance of vaginal pH testing for bacterial vaginosis improved by increasing the cutoff to 5·5, followed by confirmatory testing (sensitivity 73·6%, specificity 100%). The WHO algorithms had moderate sensitivity and poor specificity for all infections compared with gold standard testing: C trachomatis sensitivity 58·3%, specificity 44·7%; N gonorrhoeae sensitivity 66·0%, specificity 45·2%; T vaginalis sensitivity 60·4%, specificity 45·6%; bacterial vaginosis sensitivity 61·6%, specificity 46·0%; and vulvovaginal candidiasis sensitivity 74·6%, specificity 50·6%. Two participants attended additional visits because they had a mild allergic reaction to metronidazole. Staff and participants considered point-of-care testing feasible and acceptable. Interpretation Point-of-care testing for urogenital infections might improve case-finding and infection management and is feasible in resource-poor settings. Point-of-care tests should be further developed, including those targeting multiple conditions. Additional studies in other populations, including populations with low prevalence of sexually transmitted and urogenital infections, are warranted. Funding European and Developing Countries Clinical Trials Partnership.

Targeted point-of-care testing compared with syndromic management of urogenital infections in women (WISH): a cross-sectional screening and diagnostic accuracy study

BackgroundMycoplasma genitalium is associated with genital discharge syndrome, but limited prevalence data are available in South Africa. The prevalence rates of M. genitalium infection and human immunodeficiency virus (HIV) coinfection were determined in urogenital specimens collected from male and

The Prevalence of Mycoplasma genitalium and Association With Human Immunodeficiency Virus Infection in Symptomatic Patients, Johannesburg, South Africa, 2007-2014.

Uptake of and factors associated with testing for sexually transmitted infections in community-based settings among youth in Zimbabwe: a mixed-methods study

Introduction. Trichomoniasis is nowadays the most prevalent non-viral sexually transmitted infection in the world. In Senegal, the epidemiology of trichomoniasis is not well known. The current study aimed at assessing the prevalence and factors associated with T. vaginalis infection among women with vaginal discharge. Methods. A retrospective analysis of laboratory records from patients referred at the Fann Teaching Hospital in Dakar, Senegal, for vaginal discharge was carried out. The study covered the period from 2006 to 2011. For each participating woman, a vaginal swab was collected and a wet mount smear performed immediately. Optic microscopic examination with 40x magnification was done to detect T. vaginalis and assess biological modifications such as presence of epithelial cells, white blood cells, and red blood cells. A gram stained smear was also performed and examined under oil immersion (100x magnification) to assess the vaginal flora. Results. Overall, 3893 women were enrolled with a mean age at 31.2 ± 10 years. The prevalence of Trichomoniasis represented 4.8%, 95%CI(3.1-5.7) and it was lower among women less than 30 years (4.1%), while divorced women more likely to be infected compared to married and single women (aOR:2.1, 95%CI (1.2-3.7)). Trichomoniasis was associated with abnormal vaginal flora such as type III (aOR:2.6, 95%CI(1.5-4.4)) and type IV (aOR:3.3, 95%CI(2.1-5.3)). In addition, patients with erythrocytes excretion were more likely to be infected by T. vaginalis (aOR:2.8, 95%CI(1.9-3.9). Conclusion. Trichomonas vaginalis remains prevalent among sexually active women. Strategies aiming at improving disease awareness in these high-risk groups are needed to improve trichomoniasis prevention but extensive epidemiological data are still needed for a better understanding of the disease transmission dynamic.

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A Study of Trichomonas vaginalis Infection and Correlates in Women with Vaginal Discharge Referred at Fann Teaching Hospital in Senegal

Molecular testing is rapidly becoming an integral component of global tuberculosis (TB) control. Uncommon mechanisms of resistance escape detection by these platforms and undermine our ability to contain outbreaks. This article is a systematic review of published articles that reported isoniazid (INH) resistance-conferring mutations between September 2013 and December 2019. The genes katG, inhA, fabG1, and the intergenic region oxyR'-ahpC were considered in this review. Fifty-two articles were included describing 9,306 clinical isolates (5,804 INHR, 3,502 INHS) from 31 countries. The three most frequently mutated loci continue to be katG315 (4,271), inhA-15 (787), and inhA-8 (106). However, the diagnostic value of inhA-8 is far lower than previously thought, only appearing in 25 (0.4%) INHR isolates lacking the first two mutations. We catalogued 45 new loci (29 katG, nine inhA, seven ahpC) associated with INH resistance and identified 59 loci (common to this and previous reviews) as a reliable basis for molecular diagnostics. Including all observed mutations provides a cumulative sensitivity of 85.6%. In 14.4% of resistant isolates no mechanism of resistance was detected, making them likely to escape molecular detection, and in case of mono INH resistance likely to convert to MDR-TB. Integrating the information cataloged in this study into current diagnostic tools is essential for combating the emergence of MDR-TB, and its exclusion can lead to an unintended selection against common mechanisms and to diversifying evolution. Observation of many low-frequency resistance-conferring mutations points to an advantage of WGS for diagnostics. Finally, we provide five recommendations for future diagnostic platforms.

Systematic Review of Mutations Associated with Isoniazid Resistance Points to Continuing Evolution and Subsequent Evasion of Molecular Detection, and Potential for Emergence of Multidrug Resistance in Clinical Strains of Mycobacterium tuberculosis.

IntroductionSymptomatic vaginal discharge is a common gynecological condition managed syndromically in most developing countries. In Zimbabwe, women presenting with symptomatic vaginal discharge are treated with empirical regimens that commonly cover both sexually transmitted infections (STIs) and r

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The Etiology of Vaginal Discharge Syndrome in Zimbabwe: Results from the Zimbabwe STI Etiology Study.

Background: Multidrug-resistant tuberculosis (MDR-TB) is a public health concern globally. MDR-TB is defined as resistance to rifampicin (RIF) and isoniazid (INH), the two-major anti-TB first-line TB treatment drugs. Rapid identification of MDR-TB can contribute significantly to the control of TB. The GenoType® MTBDRplus Ver 2.0 assay is a molecular assay used to detect genetic mutations that result in RIF and INH resistance. The aim of this study was to validate the performance of the GenoType® MTBDRplus Ver 2.0 assay for the detection of INH and RIF resistance. Methods: Fifty-five stored Mycobacterium tuberculosis isolates were tested using both the mycobacterial growth indicator tube (MGIT), antimicrobial susceptibility testing (AST), and the GenoType® MTBDRplus Ver 2.0 assay. The MGIT AST was done according to the BBL MGIT AST SIRE system with RIF and INH final critical concentrations of 1.0 μg/ml and 0.1 μg/ml, respectively. The GenoType® MTBDRplus assay (Hain Lifescience, Germany) was performed following the manufacturer's instructions. Results: The GenoType® MTBDRplus Ver 2.0 assay had a sensitivity, specificity, positive predictive value, and negative predictive value of 100% for INH and RIF resistance. The intra-assay precision for the assay was 100%. Conclusion: The GenoType® MTBDRplus Ver 2.0 assay's sensitivity and specificity show that the assay is highly accurate for the detection of RIF and INH resistance and thus can be used as an alternate platform due to its shorter results turnaround time.

Validation of the GenoType® MTBDRplus Ver 2.0 assay for detection of rifampicin and isoniazid resistance in Mycobacterium tuberculosis complex isolates at UZCHS-CTRC TB research laboratory.

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Nicholas Dhibi

Papers

The Etiology of Vaginal Discharge Syndrome in Zimbabwe: Results from the Zimbabwe STI Etiology Study.

Validation of the GenoType® MTBDRplus Ver 2.0 assay for detection of rifampicin and isoniazid resistance in Mycobacterium tuberculosis complex isolates at UZCHS-CTRC TB research laboratory.

SARS-CoV-2 seroprevalence among women living with HIV on life-long antiretroviral therapy (ART) and their children in Zimbabwe – PEPFAR-PROMOTE Study